NEW YORK – German cancer genetics firm Mainz Biomed said Wednesday that it has contracted with diagnostics developer DCN Dx to advance Mainz's ColoAlert assay, an early detection test for colorectal cancers that combines fecal immunochemical testing and DNA analysis.
Under the agreement, Emily Friedland, VP of clinical research at DCN Dx, will spearhead the preparation and initiation of a European clinical study evaluating the potential to integrate a portfolio of recently acquired novel mRNA biomarkers into ColoAlert.
Licensed from Canadian firm Socpra Sciences Santé Et Humaines in early January, Mainz said these biomarkers have demonstrated the potential to detect precancerous lesions including advanced adenomas.
The new study is expected to begin in the first half of 2022. Under the companies' agreement, DCN Dx will be responsible for the selection of additional clinical research organizations and will assist Mainz's management with the development of study protocols and associated clinical processes.
Financial terms were not disclosed.
"If this study proves statistically significant, it will position ColoAlert as the most comprehensive and accurate CRC self-administered screening test on the market, as its enhanced technical profile will detect cancerous polyps with a high degree of accuracy," Mainz CEO Guido Baechler said in a statement.
Mainz said the study results could also help inform a planned US study, intended to support an application for regulatory clearance in the US. In Europe, the firm currently markets ColoAlert via partnerships with third-party laboratories for test kit processing.